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Tecentriq is a brand name for Atezolizumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Urothelial carcinoma (UC) Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic UC: after prior platinum-containing chemotherapy, or who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1). Early-stage…
Verbatim from this product's EMA label. Tap a section to expand.
Tecentriq must be initiated and supervised by physicians experienced in the treatment of cancer. 1). 1). 4 Posology The recommended dose of Tecentriq is either 840 mg administered intravenously every two weeks, or 1 200 mg administered intravenously every three weeks, or 1 680 mg administered intravenously every four weeks, as presented in Table 1.
1). 1L metastatic NSCLC 1L platinum-ineligible NSCLC Early-stage NSCLC 840 mg every 2 weeks or 1 200 mg every 3 weeks or 1 680 mg every 4 weeks For 1 year unless disease recurrence or unacceptable toxicity. Treatment duration for more than 1 year was not studied.
2L UC 840 mg every 2 weeks or 1 200 mg every 3 weeks or 1 680 mg every 4 weeks Until loss of clinical benefit or unmanageable toxicity. 2L NSCLC Tecentriq combination therapy 1L non-squamous NSCLC with bevacizumab, paclitaxel, and carboplatin Induction and maintenance phases: 840 mg every 2 weeks or 1 200 mg every 3 weeks or 1 680 mg every 4 weeks Tecentriq should be administered first when given on the same day.
Induction phase for combination partners (four or six cycles):
Bevacizumab, paclitaxel, and then carboplatin are administered every three weeks.
Maintenance phase (without chemotherapy):
Bevacizumab every 3 weeks. Until disease progression or unmanageable toxicity. , an initial disease progression followed by tumour shrinkage) have been observed with continued Tecentriq treatment after disease progression. Treatment beyond disease progression may be considered at the discretion of the physician.
1L non-squamous NSCLC with nab-paclitaxel and carboplatin Induction and maintenance phases: 840 mg every 2 weeks or 1 200 mg every 3 weeks or 1 680 mg every 4 weeks Tecentriq should be administered first when given on the same day.
Induction phase for combination partners (four or six cycles):
Nab- paclitaxel, and carboplatin are administered on day 1; in addition, Until disease progression or unmanageable toxicity. , an initial disease progression followed by tumour shrinkage) have been observed with continued Tecentriq treatment after disease progression.
Summary of the safety profile The safety of atezolizumab as monotherapy is based on pooled data in 5 039 patients across multiple tumour types. 2%). 19 The safety of atezolizumab given in combination with other medicinal products, has been evaluated in 4 535 patients across multiple tumour types.
4%). Use of atezolizumab in the adjuvant NSCLC setting The safety profile of atezolizumab in the adjuvant setting in the non-small cell lung cancer (NSCLC) patient population (IMpower010) was generally consistent with the overall pooled monotherapy safety profile in the advanced setting.
4% in the pooled monotherapy population with advanced disease. No new immune-mediated adverse reactions were identified in the adjuvant setting. 3%). Nausea, diarrhoea, stomatitis, fatigue, pyrexia, mucosal inflammation, decreased appetite, weight decreased, hypertension and proteinuria were reported higher (5% difference) in patients receiving atezolizumab in combination with bevacizumab, paclitaxel and carboplatin.
Other clinically significant adverse events which were observed more frequently in the atezolizumab, bevacizumab, paclitaxel, and carboplatin arm were epistaxis, haemoptysis, cerebrovascular accident, including fatal events. 4. Tabulated list of adverse reactions The adverse reactions (ARs) are listed by MedDRA system organ class (SOC) and categories of frequency in Table 3 for atezolizumab given as monotherapy or as combination therapy.
Adverse reactions known to occur with atezolizumab or chemotherapies given alone may occur during treatment with these medicinal products in combination, even if these reactions were not reported in clinical trials with combination therapy.
The following categories of frequency have been used: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 11 Immune-mediated adverse reactions Most immune-mediated adverse reactions occurring during treatment with atezolizumab were reversible with interruptions of atezolizumab and initiation of corticosteroids and/or supportive care.
Immune-mediated adverse reactions affecting more than one body system have been observed. Immune-mediated adverse reactions with atezolizumab may occur after the last dose of atezolizumab. For suspected immune-mediated adverse reactions, thorough evaluation to confirm aetiology or exclude other causes should be performed.
Based on the severity of the adverse reaction, atezolizumab should be withheld and corticosteroids administered. Upon improvement to Grade ≤ 1, corticosteroid should be tapered over ≥ 1 month. Based on limited data from clinical trials in patients whose immune-mediated adverse reactions could not be controlled with systemic corticosteroid use, administration of other systemic immunosuppressants may be considered.
8). In patients with pre-existing autoimmune disease (AID), data from observational studies suggest that the risk of immune-mediated adverse reactions following immune checkpoint inhibitor therapy may be increased as compared with the risk in patients without pre-existing AID.
In addition, flares of the underlying AID were frequent, but the majority were mild and manageable. 8). Patients should be monitored for signs and symptoms of pneumonitis and causes other than immune-mediated pneumonitis should be ruled out.
Treatment with atezolizumab should be withheld for Grade 2 pneumonitis, and 1 to 2 mg/kg body weight (bw)/day prednisone or equivalent should be started. If symptoms improve to ≤ Grade 1, corticosteroids should be tapered over ≥ 1 month.
1.
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Treatment beyond disease progression may be 5 Indication Recommended dose and schedule Duration of treatment nab-paclitaxel is administered on days 8 and 15 of each 3-weekly cycle. considered at the discretion of the physician. 1L ES-SCLC with carboplatin and etoposide Induction and maintenance phases: 840 mg every 2 weeks or 1 200 mg every 3 weeks or 1 680 mg every 4 weeks Tecentriq should be administered first when given on the same day.
Induction phase for combination partners (four cycles):
Carboplatin, and then etoposide are administered on day 1; etoposide is also administered on days 2 and 3 of each 3-weekly cycle. Until disease progression or unmanageable toxicity. , an initial disease progression followed by tumour shrinkage) have been observed with continued Tecentriq treatment after disease progression.
Treatment beyond disease progression may be considered at the discretion of the physician. 1L unresectable locally advanced or metastatic TNBC with nab-paclitaxel 840 mg every 2 weeks or 1 200 mg every 3 weeks or 1 680 mg every 4 weeks Tecentriq should be administered prior to nab-paclitaxel when given on the same day.
Nab-paclitaxel should be administered at 100 mg/m2 on days 1, 8, and 15 of each 28-day cycle. Until disease progression or unmanageable toxicity. Advanced or unresectable HCC with bevacizumab 840 mg every 2 weeks or 1 200 mg every 3 weeks or 1 680 mg every 4 weeks Tecentriq should be administered prior to bevacizumab when given on the same day.
Bevacizumab is administered at 15 mg/kg body weight (bw) every 3 weeks. Until loss of clinical benefit or unmanageable toxicity. Delayed or missed doses If a planned dose of Tecentriq is missed, it should be administered as soon as possible.
The schedule of administration must be adjusted to maintain the appropriate interval between doses. Dose modifications during treatment Dose reductions of Tecentriq are not recommended. 5 to 3 x ULN) Withhold Tecentriq Treatment may be resumed when the event improves to Grade 0 or Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day Grade 3 or 4: (ALT or AST > 5 x ULN or blood bilirubin > 3 x ULN) Permanently discontinue Tecentriq Hepatitis in patients with HCC If AST/ALT is within normal limits at baseline and increases to > 3 x to ≤ 10x ULN or […]
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Table 3:
Summary of adverse reactions occurring in patients treated with atezolizumab Atezolizumab monotherapy Atezolizumab in combination therapy Infections and infestations Very common urinary tract infectiona lung infectionb Common sepsisaj Rare cytomegalovirus infection cytomegalovirus infection Blood and lymphatic system disorders Very common anaemia, thrombocytopeniad, neutropeniae, leukopeniaf Common thrombocytopeniad, neutropeniae lymphopeniag 20 Atezolizumab monotherapy Atezolizumab in combination therapy Rare haemophagocytic lymphohistiocytosis, autoimmune haemolytic anaemiaav haemophagocytic lymphohistiocytosis, autoimmune haemolytic anaemiaav Immune system disorders Common infusion-related reactionh infusion-related reactionh Rare sarcoidosisar Endocrine disorders Very common hypothyroidismi Common hypothyroidismi, hyperthyroidismj hyperthyroidismj Uncommon diabetes mellitusk, adrenal insufficiencyl, hypophysitism hypophysitism Metabolism and nutrition disorders Very common decreased appetite decreased appetite Common hypokalaemiaae, hyponatraemiaaf, hyperglycaemia, hypoalbuminaemia, hypophosphataemia, hypocalcaemia hypokalaemiaae, hyponatraemiaaf, hypomagnesaemian, hypoalbuminaemia, hypophosphataemia, hypocalcaemia Nervous system disorders Very common headache peripheral neuropathyo, headache Common peripheral neuropathyo syncope, dizziness Uncommon Guillain-Barré syndromep, meningoencephalitisq Rare myasthenic syndromer, facial paresis, myelitis facial paresis Eye disorders Uncommon uveitisas Rare uveitisas Cardiac disorders Common pericardial disordersao Uncommon pericardial disordersao Rare myocarditiss Vascular disorders Very common hypertensionai Common hypotension Respiratory, thoracic, and mediastinal disorders Very common dyspnoea, cough dyspnoea, cough, nasopharyngitisam Common pneumonitist, hypoxiaag, nasopharyngitisam dysphonia Gastrointestinal disorders Very common nausea, vomiting, diarrhoeau nausea, vomiting, diarrhoeau, constipation 21 a Includes reports of urinary tract infection, cystitis, pyelonephritis, escherichia urinary tract infection, urinary tract infection bacterial, kidney infection, pyelonephritis acute, pyelonephritis chronic, pyelitis, renal abscess, streptococcal urinary tract infection, urethritis, urinary tract infection fungal, urinary tract infection pseudomonal.
b Includes reports of pneumonia, bronchitis, lower respiratory tract infection, infectious pleural effusion, tracheobronchitis, atypical pneumonia, lung abscess, infective exacerbation of chronic obstructive airways […]
Treatment with atezolizumab may be resumed if the event improves to ≤ Grade 1 within 12 weeks, and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day. Treatment with atezolizumab must be permanently discontinued for Grade 3 or 4 pneumonitis.
8). Patients should be monitored for signs and symptoms of hepatitis. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin should be monitored prior to initiation of treatment, periodically during treatment with atezolizumab and as indicated based on clinical evaluation.
5 to 3 x ULN) persists for more than 5 to 7 days, and 1 to 2 mg/kg bw/day of prednisone or equivalent should be started. If the event improves to ≤ Grade 1, corticosteroids should be tapered over ≥ 1 month. Treatment with atezolizumab may be resumed if the event improves to ≤ Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day.
0 x ULN or blood bilirubin > 3 x ULN). For patients with HCC, treatment with atezolizumab should be withheld if ALT or AST increases to > 3 to ≤ 10 x ULN from normal limits at baseline, or > 5 to ≤ 10 x ULN from > 1 ULN to ≤ 3 x ULN 12 at baseline, or > 8 to ≤ 10 x ULN from > 3 ULN to ≤ 5 x ULN at baseline, and persists for more than 5 to 7 days, and 1 to 2 mg/kg bw/day of prednisone or equivalent should be started.
If the event improves to ≤ Grade 1, corticosteroids should be tapered over ≥ 1 month. Treatment with atezolizumab may be resumed if the event improves to ≤ Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day.
Treatment with atezolizumab must be permanently discontinued if ALT or AST increases to > 10 x ULN or total bilirubin increases > 3 x ULN). 8). Patients should be monitored for signs and symptoms of colitis. Treatment with atezolizumab should be withheld for Grade 2 or 3 diarrhoea (increase of ≥ 4 stools/day over baseline) or colitis (symptomatic).
For Grade 2 diarrhoea or colitis, if symptoms persist > 5 days or recur, treatment with 1 to 2 mg/kg bw/day prednisone or equivalent should be started. For Grade 3 diarrhoea or colitis, treatment with intravenous corticosteroids (1 to 2 mg/kg bw/day methylprednisolone or equivalent) should be started.
Once symptoms improve, treatment with 1 to 2 mg/kg bw/day of prednisone or equivalent should be started. If symptoms improve to ≤ Grade 1, corticosteroids should be tapered over ≥ 1 month. Treatment with atezolizumab may be resumed if the event improves to ≤ Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day.
Treatment with atezolizumab must be permanently discontinued for Grade 4 (life threatening; urgent intervention indicated) diarrhoea or colitis. The potential complication of gastrointestinal perforation associated with colitis should be taken into consideration.
8). Patients should be […]